Obesity is a growing epidemic with approximately two-thirds of the American population being overweight or obese. Obesity is a state of excess adiposity, and the current treatment options include lifestyle modification, pharmacotherapy, and bariatric surgery. Lifestyle modification is only effective for five percent of those who try it, pharmacotherapy is limited in efficacy in addition to adverse side effects, and bariatric surgery qualification is rigorous, resulting in a very small patient pool that end up receiving surgery.
Scintigraphy and MRI provide evidence of disrupted motility patterns in the gastrointestinal (GI) tract, but they do not elucidate the underlying electrical patterns of the stomach, and thus do not explain why and how these patterns occur. Direct measurement of myolectric activity is possible by the placement of serosal electrodes on the stomach, but this requires open surgery or laparotomy. Prior attempts to record gastric activity with mucosal electrodes have had limited success due to easy dislodgement, the inability to be directed to specific regions in the stomach, and a limited number of available electrodes on existing devices. Furthermore, the clinical application of therapies that rely on mapping the stomach has not been realized due to the deficiencies noted above. Additionally, there is no strong clinical data to provide insight into how stomach dysrhythmias may contribute to conditions such as obesity.
Many patients indicate a lack of satiety before bariatric surgery. Gastric dysrhythmia may be a contributing cause of obesity. For example, accelerated gastric emptying of solids (among other mechanisms of action) could be linked to the feeling of a lack of satiety, because food may not stay in the stomach for long enough to sufficiently signal satiety. A link also has been made between faster gastric emptying and increased food intake. However, data substantiating this link is inconsistent. Delayed gastric empting is also linked to obesity. Abnormal gastric motility may be linked to obesity by differing mechanisms of action. Medical practitioners are also unable to accurately predict the efficacy of certain obesity treatments before treatments are performed.
Thus, there remains a need for a GI mapping tool, and treatment options that are acceptable to a large potential patient pool.